Study on Vistusertib (AZD2014) for Recurrent Grade II-III Meningiomas
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT03071874
This clinical trial is exploring the use of a chemotherapy drug called AZD2014 (vistusertib) to treat meningiomas that have returned after previous treatment. The study aims to determine if this drug can help shrink or slow the growth of these brain tumors.
Patient Parameters
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Program Overview
This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new treatment, AZD2014, for recurrent grade II-III meningiomas. The U.S. Food and Drug Administration (FDA) has not yet approved AZD2014 for any disease. Researchers want to see if AZD2014 can reduce the size of meningiomas or slow their growth. Laboratory studies suggest that AZD2014 blocks certain pathways important for tumor growth and survival. The study will also monitor the safety of AZD2014 by observing participants' physical health, symptoms, tumor size changes, and lab results. AZD2014 is being tested in various cancers, either alone or with other cancer treatments, to find the best dose and reduce side effects.
Description
This Phase II clinical trial is investigating the use of AZD2014, a drug not yet approved by the FDA, to treat recurrent grade II-III meningiomas. The goal is to see if AZD2014 can shrink or slow the growth of these tumors. Laboratory research has shown that AZD2014 can block pathways that help meningiomas grow and survive, and it has been effective in reducing tumor cell survival in lab settings. The study will also assess the safety of AZD2014 by monitoring participants' health, symptoms, tumor size, and lab results. AZD2014 is being studied in various cancers, either alone or with other treatments, to determine the best dose and minimize side effects.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of grade II-III meningioma that has returned or progressed after previous treatment.
- Must be willing to undergo regular MRI scans of the brain.
- Must have at least one tumor that can be measured by MRI.
- Must have had previous surgery and radiation therapy for the meningioma.
- Must have had less than three prior chemotherapy treatments for the meningioma.
- Must provide a tumor sample for analysis.
- Must be 18 years or older.
- Must be in good overall health with a performance status score of 0 to 2.
- Must have a life expectancy of more than three months.
- Must have normal organ and bone marrow function based on specific blood tests.
- Women must use effective contraception and have a negative pregnancy test if of childbearing potential.
- Men must use effective contraception if sexually active with a woman of childbearing potential.
- Must be able to understand and sign a consent form.
- Must be able to swallow pills.
Exclusion Criteria
- Cannot have a diagnosis of NF2 or certain genetic conditions related to NF2.
- Cannot have had only a biopsy or more than two rounds of radiation for meningioma.
- Cannot have had recent chemotherapy, radiation, or other cancer treatments within 14 days before the study.
- Cannot have unresolved side effects from previous cancer treatments.
- Cannot have had major surgery within four weeks before the study.
- Cannot be participating in another clinical trial within 21 days before the study.
- Cannot have allergies to AZD2014 or similar drugs.
- Cannot be taking certain medications that interact with AZD2014.
- Cannot have certain pre-existing health conditions, such as severe heart or lung disease, uncontrolled infections, or other serious illnesses.
- Cannot have a history of other cancers unless treated and inactive for at least five years.
- Cannot have had recent heart procedures or conditions like heart attack or stroke.
- Cannot have abnormal heart function or certain heart conditions.
- Cannot have uncontrolled diabetes or high blood sugar.
- Cannot be pregnant or breastfeeding.
- Cannot have HIV and be on antiretroviral therapy.
- Cannot be involved in the planning or conduct of the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern University | 60611 | Chicago | Illinois |
| Massachusetts general Hospital | 02114 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
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